Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients

• ClinicalTrials.gov Identifier: NCT02172586
• Recruitment Status: Completed
• First Posted: June 24, 2014
• Last Update Posted: June 24, 2014
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

Brief Summary:

Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).

Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM

Safety:

Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters

Condition or disease	Intervention/treatment	Phase
Hypertension	Drug: Telmisartan; Drug: Losartan; Drug: Hydrochlorothiazide	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 363 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
• Study Start Date: January 2000
• Actual Primary Completion Date: January 2002

Arms and Interventions

Arm	Intervention/treatment
Experimental: Telmisartan	Drug: Telmisartan
Experimental: Telmisartan + Hydrochlorothiazide	Drug: Telmisartan; Drug: Hydrochlorothiazide
Active Comparator: Losartan	Drug: Losartan
Active Comparator: Losartan + Hydrochlorothiazide	Drug: Losartan; Drug: Hydrochlorothiazide

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment [ Time Frame: Baseline and week 12 ]

Secondary Outcome Measures :

1. Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study [ Time Frame: Baseline and week 24 ]
2. Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval [ Time Frame: Baseline, week 12 and 24 ]
3. Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP) [ Time Frame: Baseline, week 12 and 24 ]
4. Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP [ Time Frame: Baseline, week 12 and 24 ]
5. Changes from baseline in SBP/DBP of 24 hours mean ABPM [ Time Frame: Baseline, week 12 and 24 ]
6. Comparison of SBP/DBP ABPM tracing profile [ Time Frame: Week 12 and 24 ]
7. Smoothness index in comparison with baseline [ Time Frame: Baseline, week 12 and 24 ]
8. Number of responders [ Time Frame: Week 12 and 24 ]
9. Number of controlled responders [ Time Frame: Week 12 and 24 ]
10. Number of patients who withdraw due to lack of efficacy [ Time Frame: 24 weeks ]
11. Number of patients with adverse events [ Time Frame: 24 weeks ]
12. Number of patients who withdraw due to adverse events [ Time Frame: 24 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and < 110 mmHg and systolic blood pressure (SBP) < 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
• Written informed consent

Exclusion Criteria:

• Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation > 1 year prior to start wash-out phase or surgically sterile
• Secondary hypertension
• Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
• Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
• Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
• Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
• Angina pectoris or myocardial infarction
• Cardiac surgery within the past 3 months prior to start the wash-out period
• Stroke within the past 6 months prior to start the wash-out period
• Renal insufficiency defined as creatininaemia > 2mg/dl
• Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney
• Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range
• Clinically significant metabolic and endocrine disease
• Autoimmune disease
• Previous history of angioedema
• Body mass index > 30kg/m2
• Arm circumference > 32 cm
• Any condition that may be likely to compromise patients participation to the trial (alcohol or drug abuse, disability illness, etc.)
• Concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure
• Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
• Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial
• Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, losartan, HCTZ)
• Predictable lack of patient co-operation

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02172586 History of Changes
• Other Study ID Numbers: 502.316
• First Posted: June 24, 2014
• Last Update Posted: June 24, 2014
• Last Verified: June 2014

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases; Losartan; Hydrochlorothiazide; Telmisartan; Anti-Arrhythmia Agents; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Diuretics; Natriuretic Agents; Physiological Effects of Drugs; Sodium Chloride Symporter Inhibitors; Membrane Transport Modulators